Deployment rods for use with implantable hernia prostheses

ABSTRACT

An implantable prosthesis device and system for insertion, deployment, and fixation of a hernia prosthesis. The system includes two or more deployment rods removably affixed to the prosthesis. Each rod extends across a majority of a width of the prosthesis and beyond one end of the width of the prosthesis. The rods are arranged generally parallel to one another when in a rolled configuration. The rods are separate, physically noncontiguous wire rods that are not operably coupled to one another. The rods provide structural reinforcement and increased rigidity across the width of the implantable hernia prosthesis while maintaining the ability of the prosthesis to experience bends in its length. In this way, the rods allow a user to separately manipulate discrete portions of the prosthesis while to maintaining the ability of the prosthesis to be rolled up and inserted into the body of a patient through, e.g., a trocar.

RELATED APPLICATION

This application claims priority to, and the benefit of, co-pending U.S.Provisional Application 61/731,909, filed Nov. 30, 2012, for all subjectmatter common to both applications. The disclosure of said provisionalapplication is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to deployment devices suitable for usewith implantable prostheses used in hernia repair. More particularly,the present invention relates to deployment rods configured tofacilitate handling and deployment of implantable hernia prosthesesduring laparoscopic surgical procedures.

BACKGROUND OF THE INVENTION

In laparoscopic hernia repair, implantable hernia prostheses areutilized to provide reinforcement and support at the hernia defect. Suchimplantable hernia prostheses or other sheet-like prostheses (e.g.,films, surgical fabrics, and the like) are rolled up and inserted (e.g.,housed within a trocar cannula) through a small incision cut into theskin and abdominal wall. Generally, such implantable hernia prosthesesare flat sheets (e.g., of woven or knitted surgical fabric) that aretrimmed to fit the anatomy of the defect site as needed prior to beingrolled up and inserted through the incision. Once inserted, theimplantable hernia prosthesis can be unrolled and affixed to the defectsite using sutures, tacks, or the like. The implantable herniaprosthesis can integrate into the surrounding tissue via tissueingrowth.

However, manipulating implantable hernia prostheses during laparoscopicprocedures presents numerous challenges to a surgeon. For example,trocars only provide a limited range of motion and require the user togrip small instruments such as graspers when manipulating (e.g.,unrolling, positioning, etc.) the implantable hernia prosthesis.Moreover, in many instances, the mechanical and physical conditions ofmany implantable hernia prostheses change upon exposure to bodilyconditions and environments, such as bodily temperatures, body fluids,and the like. In particular, when exposed to moisture, such implantablehernia prostheses can hydrate and become less stiff, making them moredifficult to deploy or unroll. Additionally, in some instances, theimplantable hernia prosthesis may include a tissue separating layerintended to minimize visceral tissue attachment to the prosthesis. Suchtissue separating layers can hydrate, warm up, and soften, making themmore fragile and prone to tearing, abrasions, or rupture, therebycomplicating a user's ability to handle and place the implantable herniaprosthesis during surgery and implantation. Such self-adhering layerscan further complicate a user's ability to handle and place theimplantable hernia prosthesis during surgery and implantation.

Additionally, in abdominal and pelvic laparoscopic procedures, theinsertion, placement, and fixation of such implantable prostheses proveeven more challenging. Due to the use of extremely delicate prosthesesin such surgical procedures, the aforementioned concerns are magnifiedby the increased risk of rupture or tear. As such, even routine handlingof the extremely delicate prostheses can be associated with risk offailure of the delicate prosthesis in such procedures as currentlyperformed by doctors.

SUMMARY

There is a need in the art for a deployment device that enables theconvenient delivery, deployment, and placement of implantable herniaprostheses (e.g., meshes, films, patches, fabrics, etc.). The presentinvention is directed toward solutions to address this and other needs,in addition to having other desirable characteristics that will beappreciated by one of skill in the art upon reading the presentspecification.

In accordance with an example embodiment of the present invention, asystem is provided. The system can include a prosthesis including afirst flexible mesh sheet structure. Two or more elongate rods each canbe removably coupled with the prosthesis and each can be more rigid thanthe mesh sheet structure, in such a way that the combination of the twoor more elongate rods with the mesh sheet structure rigidifies the meshsheet structure along a length of each of the two or more elongate rods.The system can be configured to be rolled in a direction substantiallyorthogonal to central longitudinal axes of the two or more elongate rodsin such a way that all or substantially all of the mesh sheet structureforms one or more rolls without bending the two or more elongate rods.

In accordance with aspects of the present invention, the two or moreelongate rods can be separate and distinct from each other and two ofthe two or more elongate rods can be independently moveable relative toeach other. One or more fastening mechanisms can couple the two or moreelongate rods to the first mesh sheet structure of the prosthesis. Eachone of the two or more elongate rods can be slidable out of the one ormore fastening mechanisms in a direction generally along the centrallongitudinal axis of that one of the two or more elongate rods. The oneor more fastening mechanisms can be configured to be cut to release thetwo or more elongate rods and can be adapted to be removed from the meshsheet structure. A second flexible mesh sheet structure can be coupledto and can form a layer on the first mesh sheet structure. The two ormore elongate rods can be disposed between the first and second meshsheet layers which removably couple the two or more elongate rods to thesheet in such a way that the two or more elongate rods are slidable outfrom between the first and second mesh sheet structures. The prosthesiscan include a second flexible mesh sheet structure coupled to andforming a layer on the first mesh sheet structure, and each of the twoor more elongate rods can be affixed to the first flexible mesh sheetstructure or the second flexible mesh sheet structure.

In accordance with yet further aspects of the present invention, atleast one of the two or more elongate rods coupled to the prosthesis canextend beyond and exterior to a perimeter edge of the prosthesis. Atleast one of the two or more elongate rods coupled to the prosthesis canbe graspable and maneuverable by a laparoscopic grasper or otherseparate tool. Each of the two or more elongate rods can extend across amajority of a dimension of the prosthesis. A first of the two or moreelongate rods can be disposed at a first end of the prosthesis and asecond of the two or more elongate rods is disposed at a second end ofthe prosthesis, the second end of the prosthesis being opposite thefirst end. The two or more elongate rods further can include a third roddisposed between the first and second rods at a central portion of theprosthesis. The two or more elongate rods can have a rigidity suitablefor using the two or more elongate rods to manipulate and position theprosthesis at a target site (e.g., pushing, pulling, rotating, pivoting,lateral movement, raising, lowering, and the like). Each of the two ormore elongate rods can include a wire rod, a plastic rod, or a rodconstructed of another material.

In accordance with an example embodiment of the present invention, amethod for deploying a mesh prosthesis using a system comprising aprosthesis comprising a first flexible mesh sheet structure, and two ormore elongate rods each being removably coupled with the prosthesis andeach being more rigid than the mesh sheet structure in such a way thatthe combination of the two or more elongate rods with the mesh sheetstructure rigidifies the mesh sheet structure along a length of each ofthe two or more elongate rods, is provided. The method can includeproviding a rolled prosthesis in which, using the two or more elongaterods, the prosthesis is rolled in a direction substantially orthogonalto a central longitudinal axes of the two or more elongate rods in sucha way that all or substantially all of the mesh sheet structure formsone or more rolls without bending the two or more elongate rods. Themethod can continue with inserting the prosthesis into a bodily cavity,unrolling the prosthesis, using the two or more elongate rods, andremoving the two or more elongate rods from the prosthesis.

In accordance with aspects of the present invention, wherein the two ormore elongate rods can be separate and distinct from each other and twoof the two or more elongate rods can be independently moveable relativeto each other. One or more fastening mechanisms can be provided couplingthe two or more elongate rods to the first mesh sheet structure of theprosthesis.

In accordance with aspects of the present invention, the step ofremoving the two or more elongate rods can include sliding the two ormore elongate rods out of the one or more fastening mechanisms in adirection generally along the central longitudinal axis of eachrespective rod of the two or more elongate rods.

In accordance with aspects of the present invention, the prosthesis canfurther include a second flexible mesh sheet structure coupled to andforming a layer on the first mesh sheet structure. The two or moreelongate rods are can be disposed between the first and second meshsheet layers which removably couple the two or more elongate rods to thesheet in such a way that the step of removing the two or more elongaterods can include sliding the two or more elongate rods out from betweenthe first and second mesh sheet structures.

In accordance with aspects of the present invention, at least one of thetwo or more elongate rods coupled to the prosthesis can extend beyondand exterior to a perimeter edge of the prosthesis. At least one of thetwo or more elongate rods coupled to the prosthesis can be graspable andmaneuverable by a laparoscopic grasper or other separate tool. The twoor more elongate rods can have a rigidity suitable for using the two ormore elongate rods to manipulate and position the prosthesis at a targetsite, and the method can further include manipulating and positioningthe prosthesis at the target site using the two or more elongate rods.

In accordance with aspects of the present invention, the prosthesis maybe rolled at a point of manufacture or may be rolled by a user at thetime of performing the deployment method.

In accordance with an example embodiment of the present invention, asystem includes a prosthesis having a first flexible mesh sheetstructure. Two or more elongate rods can each be removably coupled withthe prosthesis and each be more rigid than the mesh sheet structure, insuch a way that the combination of the two or more elongate rods withthe mesh sheet structure rigidifies the mesh sheet structure along alength of each of the two or more elongate rods. The system can beconfigured to be rolled in a direction substantially orthogonal to acentral longitudinal axes of the two or more elongate rods in such a waythat all or substantially all of the mesh sheet structure forms one ormore rolls. The two or more elongate rods can be separate and distinctfrom each other and two of the two or more elongate rods can beindependently moveable relative to each other.

In accordance with one example embodiment of the present invention, asystem includes a prosthesis having a first flexible mesh sheetstructure. Two or more elongate rods can each be removably coupled withthe prosthesis and each be more rigid than the mesh sheet structure, insuch a way that the combination of the two or more elongate rods withthe mesh sheet structure rigidifies the mesh sheet structure along alength of each of the two or more elongate rods. The system can beconfigured to be rolled in a direction substantially orthogonal to acentral longitudinal axes of the two or more elongate rods in such a waythat all or substantially all of the mesh sheet structure forms one ormore rolls. The two or more elongate rods can be separate and distinctfrom each other and two of the two or more elongate rods can beindependently moveable relative to each other. The two or more elongaterods can have a rigidity suitable for using the two or more elongaterods to manipulate and position the prosthesis at a target site.

BRIEF DESCRIPTION OF THE FIGURES

These and other characteristics of the present invention will be morefully understood by reference to the following detailed description inconjunction with the attached drawings, in which:

FIG. 1 is a perspective view of a system including an implantable herniaprosthesis and three deployment rods coupled thereto, according to anexample embodiment of the present invention;

FIG. 2 is a top view of the system of FIG. 1, according to aspects ofthe present invention;

FIG. 3 is a perspective view of the system of FIG. 1, with theimplantable hernia prosthesis in a rolled configuration forimplantation, according to aspects of the present invention;

FIG. 4 is a perspective view of the system of FIG. 3 during deploymentof the implantable hernia prosthesis, according to aspects of thepresent invention;

FIG. 5 is a top view of a prosthesis with two deployment rods removablycoupled thereto, according to an example embodiment of the presentinvention;

FIG. 6 is a top view of a prosthesis formed of two mesh sheet structuresand having two deployment rods removably coupled thereto, according toan example embodiment of the present invention;

FIG. 7 is a top view of a prosthesis formed of two mesh sheet structuresand having two deployment rods affixed at least to a first of the twomesh sheet structures, according to an example embodiment of the presentinvention;

FIG. 8 is a top view of the prosthesis of FIG. 7, with the twodeployment rods affixed at least to a second of the two mesh sheetstructures, according to an example embodiment of the present invention;and

FIG. 9 is a flowchart illustrating a method of use of the system,according to one example embodiment of the present invention.

DETAILED DESCRIPTION

An illustrative embodiment of the present invention relates to a systemfor insertion, deployment, and/or fixation of an implantable herniaprosthesis. For example, the implantable hernia prosthesis can include aflexible mesh sheet structure, in singular form, or layered, as would beappreciated by one of skill in the art. In addition to the implantablehernia prosthesis, the system also can include two or more (e.g., three,in an example embodiment described herein) elongate deployment rodsremovably coupled with the implantable hernia prosthesis. The deploymentrods can be substantially rigid relative to the mesh sheet structure.Each of the deployment rods can have a central longitudinal axis, andthe system, in particular the implantable hernia prosthesis, can beconfigured to be rolled in a direction substantially orthogonal to thecentral longitudinal axes of the two or more deployment rods in such away that all or substantially all of the implantable hernia prosthesis(e.g., including the mesh sheet structure) forms one or more rollswithout bending the two or more elongate rods.

In general, the deployment rods provide the implantable herniaprosthesis with structural reinforcement and increased rigidity alongthe lengths of the deployment rods, without hindering the ability of theimplantable hernia prosthesis to bend orthogonally to the centrallongitudinal axes of the deployment rods. For example, in oneillustrative embodiment, the deployment rods extend across the width ofthe prosthesis, in such a way as to rigidify the width of the prosthesiswithout sacrificing the ability of the prosthesis to experience bends inits length. Stated differently, the deployment rods of such anillustrative embodiment increase the rigidity of the implantable herniaprosthesis along the width, but not the length, dimensions as indicatedin the figures. Accordingly, as stated previously, the system is capableof being rolled up in a direction substantially orthogonal to thecentral longitudinal axes of the deployment rods, thereby allowing thesystem to pass through one or more trocars (e.g., during implantation).It should be noted that the phrase “substantially orthogonal”, or“orthogonal”, when referring to the direction of roll of the prosthesisaround the deployment rods, is intended to capture a direction of rollthat is sufficient to result in the prosthesis actually wrapping aboutthe deployment rod substantially overlapping itself without spiraling inone direction or another. Sufficient illustration of this orthogonalarrangement, direction, and movement, are provided in the figures toenable one of skill in the art to appreciate the general nature of theterms and phrases without undue experimentation, such that the presentinvention is fully enabled.

As described in greater detail herein, the implantable hernia prosthesiscan include a mesh sheet structure that is more flexible than thedeployment rods. In particular, each of the deployment rods can be anelongate rod that is more rigid than the mesh sheet structure, in such away that the deployment rods rigidify the mesh sheet structure along alength of each of the deployment rods. Accordingly, the elongate rodscan be configured in this way to maintain the shape of the sheet meshstructure (e.g., and of the implantable hernia prosthesis generally)along the central longitudinal axes of the deployment rods. Furthermore,in accordance with in illustrative embodiments of the present invention,the deployment rods can have a rigidity that is sufficiently high toallow the deployment rods to: (a) support the weight of the sheet meshstructure (e.g., and of the implantable hernia prosthesis generally),and (b) serve as tools for manipulating the shape and/or position of thesheet mesh structure (e.g., and of the implantable hernia prosthesisgenerally) during rolling, insertion, deployment, and placement thereof.

In accordance with an illustrative and non-limiting embodiment of thepresent invention, the deployment rods are separate, physicallynoncontiguous, wire rods that are independently movable relative to oneanother. Furthermore, the deployment rods can be separately removable,in such a way as to enable piecewise deployment and fixation of discreteportions of the implantable hernia prosthesis, as described in greaterdetail below.

FIGS. 1 through 9, wherein like parts are designated by like referencenumerals throughout, illustrate example embodiments of a system fordeploying an implantable hernia prosthesis, according to the presentinvention. Although the present invention will be described withreference to the example embodiments illustrated in the figures, itshould be understood that many alternative forms can embody the presentinvention. For example, although for purposes of clarity the exampleembodiments are described with reference to an implantable herniaprosthesis, the present invention alternatively can be implemented inaccordance with any other suitable prosthesis. Accordingly, the presentinvention is not limited exclusively to implantable hernia prostheses,as would be appreciated by one of skill in the art upon reading thepresent specification. One of skill in the art will additionallyappreciate a variety of ways to alter the parameters of the embodimentsdisclosed, such as the size, shape, or type of elements or materials, ina manner still in keeping with the spirit and scope of the presentinvention. All such alternatives and modifications are contemplatedwithin the scope of the present invention.

FIGS. 1 and 2 depict a perspective view and a top view, respectively, ofa system 10 for inserting, deploying, and positioning an implantablehernia prosthesis 12, in accordance with an example embodiment of thepresent invention. As shown in the example embodiment of FIGS. 1 and 2,the implantable hernia prosthesis 12 includes a generally flat, flexiblesheet of mesh, as would be appreciated by one of skill in the art. Morespecifically, in the example embodiment of FIGS. 1 and 2, theimplantable hernia prosthesis 12 is constructed of a single layer of apolypropylene filament knitted mesh. Examples of polypropylene meshessuitable for use with the present invention include, but are not limitedto, C-QUR™ Mesh, C-QUR™ Mosaic Mesh, C-QUR™ Film, C-QUR FX™ Mesh,ProLite™ and ProLite Ultra™, all manufactured by Atrium MedicalCorporation of Hudson, N.H. Additional meshes manufactured by othersources are also suitable for use with the present invention, as wouldbe appreciated by one of skill in the art.

The implantable hernia prosthesis 12 has a length 20 and a width 22. Thelength 20 may be greater than the width 22, as illustrated in FIGS. 1and 2. Alternatively, in some embodiments, the width 22 is greater thanthe length 20. In yet other embodiments, the length 20 and the width 22are equal in magnitude. The implantable hernia prosthesis 12 generallyis sized and shaped to have a surface area that is larger than that of ahernia (or other bodily defect). In this way, the implantable herniaprosthesis 12 can be sized, shaped, and dimensioned to completely coverthe hole or defect upon implantation and proper placement at the defectsite. As stated previously herein, the implantable hernia prosthesis 12generally is flexible, as would be appreciated by one of skill in theart. In particular, the implantable hernia prosthesis 12 generally iscapable of being rolled up into a single-roll configuration or adouble-roll configuration, e.g., prior to implantation during usethereof.

The implantable hernia prosthesis 12 may be uncoated or may include acoating. For embodiments of the present invention in which theimplantable hernia prosthesis 12 includes a coating, the coating may beany suitable coating, including as a non-limiting example a hydrolysablebioabsorbable cross-linked fatty acid based material that includes apartially or fully cured fish oil or omega-3 fatty acid. Such a coatingcan be applied to the implantable hernia prosthesis 12 with sufficientthickness to serve as a physical protective layer between surroundingtissue and the surface of the implantable hernia prosthesis 12.Additionally, the hernia prosthesis 12 is preferably sterilized by asuitable sterilization process such as e-beam, cobalt 60 gammairradiation, and ethylene oxide gas.

In addition to the implantable hernia prosthesis 12, the system 10 ofFIGS. 1 and 2 also includes two or more elongate deployment rodsconfigured to facilitate insertion, placement, deployment, and fixationof the implantable hernia prosthesis 12. In the example embodiment ofFIGS. 1 and 2, the system 10 includes a first deployment rod 14, asecond deployment rod 16, and a third deployment rod 18. In the exampleembodiment of FIGS. 1 and 2, each of the deployment rods 14, 16, 18 is asubstantially straight (e.g., non-curved), elongate rod having a lengththat extends across at least a majority of the width 22 of theimplantable hernia prosthesis 12. In some embodiments, the deploymentrods 14, 16, 18 have a flexibility sufficient to enable the deploymentrods 14, 16, 18 to bend and conform to the contour of the shape of theabdominal wall or other hernia defect site, while still being more rigidthan the mesh hernia prosthesis 12. In the example embodiment of FIGS. 1and 2, each of the deployment rods 14, 16, 18 extends acrosssubstantially all of the width 22 of the implantable hernia prosthesis12. The deployment rods 14, 16, 18 can be generally cylindrical in shape(as shown in FIGS. 1 and 2), or can have a shape generally resembling arectangular prism, triangular pyramid, or any other suitable shape, aswould be appreciated by those of skill in the art. The deployment rods14, 16, 18 can be tapered at one or both of their ends. In the exampleembodiment of FIGS. 1 and 2, the deployment rods 14, 16, 18 are arrangedsubstantially parallel to one another, as depicted. The phrase“substantially parallel” as utilized herein is intended to have theordinary meaning as would be understood by those of skill in the art. Inparticular, the underlying motivation for the deployment rods 14, 16, 18to be arranged “substantially parallel” is so that when the prosthesisis rolled as described herein, the deployment rods 14, 16, 18 are insufficient parallel alignment with each other so as to not hinder orinterfere in the rolling process in a way such that either (i) therolling process becomes unduly difficult or impossible as a result ofsuch interference and/or the prosthesis; or (ii) limits the ability forthe rolled prosthesis to accommodate a size (e.g., maximum diameter whenrolled) sufficient for its intended usage (e.g., to fit through a trocarport). As noted in a later described embodiment, the substantiallyparallel arrangement of the deployment rods 14, 16, 18 can result uponrolling the prosthesis and not when the prosthesis is flat (e.g., seeFIG. 5 and corresponding description).

Each of the deployment rods 14, 16, 18 extends beyond an edge of theimplantable hernia prosthesis 12. Specifically, in the exampleembodiment of FIGS. 1 and 2, each of the deployment rods 14, 16, 18extends beyond the same end 28 of the width 22 of the implantable herniaprosthesis 12. Furthermore, in the example embodiment of FIGS. 1 and 2,the deployment rods 14, 16, 18 do not extend beyond the opposite end 30of the width 22 of the implantable hernia prosthesis 12.

With embodiments such as depicted in FIGS. 1 and 2, it should beappreciated that the deployment rods 14, 16, 18 can extend beyond theend 28 of the width 22 of the implantable hernia prosthesis 12 in thesame amount or in differing amounts. Furthermore, the deployment rods14, 16, 18 can span or occupy the same amount or different amounts ofthe width 22 of the implantable hernia prosthesis 12. In somealternative embodiments, one, some, or all of the deployment rods 14,16, 18 extend beyond two opposite edges of the implantable herniaprosthesis 12 (e.g., extend beyond both ends 28, 30 of the width 22 ofthe implantable hernia prosthesis 12).

In the example embodiment of FIGS. 1 and 2, the first deployment rod 14is positioned proximate a first end 24 of the length 20 of theimplantable hernia prosthesis 12 and spaced inward from the first end 24of the length 20 (e.g., by a small amount relative to the full length20, as would be appreciated by one of skill in the art upon reading thepresent specification). The second deployment rod 16 is positionedproximate or at a center or midpoint of the length 20 of the implantablehernia prosthesis 12. The third deployment rod 18 is positionedproximate a second end 26 of the length 20 of the implantable herniaprosthesis 12 that is opposite the first end 24 of the length 20 of theimplantable hernia prosthesis 12. The third deployment rod 18 is spacedinward from the second end 26 of the length 20 of the implantable herniaprosthesis 12, e.g., by a small amount relative to the full length 20 ofthe implantable hernia prosthesis 12, as would be appreciated by one ofskill in the art upon reading the present specification. Accordingly, asshown in FIGS. 1 and 2, the deployment rods 14, 16, 18 can be separateand noncontiguous with one another (e.g., not in physical contact withone another) when the implantable hernia prosthesis 12 is in theunrolled, substantially flat configuration. Furthermore, in accordancewith illustrative embodiments of the present invention, the deploymentrods 14, 16, 18 are not operably connected to one another (e.g., bysupport bars, etc.). Thus, the two outer deployment rods 14, 18 areindependently movable within a range of motion. Stated differently, eachone of the two outer deployment rods 14, 18 has a range of motionthrough which movement of the deployment rod 14, 18 along a givendistance does not have an affect on movement of the other of the twoouter deployment rods 14, 18.

The deployment rods 14, 16, 18 can be spaced apart from one anotheralong the length 20 of the implantable hernia prosthesis 12, e.g., canbe spaced apart in equal amounts as depicted in FIGS. 1 and 2.Alternatively, the deployment rods 14, 16, 18 can be separated bynon-equal amounts. The positions of the deployment rods 14, 16, 18depicted and described herein are illustrative and in no way limit thepresent invention. In general, the deployment rods 14, 16, 18 can bedisposed at any suitable positions allowing the deployment rods 14, 16,18 to aid in the handling of the implantable hernia prosthesis 12 (e.g.,during insertion, deployment, placement, and the like).

The deployment rods 14, 16, 18 are removably coupled with theimplantable hernia prosthesis 12. In illustrative embodiments, thedeployment rods 14, 16, 18 are coupled with the implantable herniaprosthesis 12 independently of one another. Stated differently, thecoupling of one of the deployment rods 14, 16, 18 does not depend uponthe coupling of any other of the deployment rods 14, 16, 18. Forexample, separate and distinct fixation mechanisms can be utilized toaffix each of the deployment rods 14, 16, 18. In general, any suitablemechanism or method may be used to affix the deployment rods 14, 16, 18to the implantable hernia prosthesis 12 in a removable and replaceablemanner allowing the subsequent removal of the deployment rods 14, 16, 18from the implantable hernia prosthesis 12. In illustrative embodiments,each of the deployment rods 14, 16, 18 are securely removably andreplaceably affixed to the implantable hernia prosthesis 12 by one ormore fastening mechanisms 32 (e.g., in the form of loops, stitches,slits, or the like). The fastening mechanisms 32 can be removable (e.g.,by cutting, unstitching, unfastening, etc.), so as to facilitate theremoval of the deployment rods 14, 16, 18. Alternatively and/oradditionally, the deployment rods 14, 16, 18 can be slideable out fromthe fastening mechanisms 32. Additionally and/or alternatively toincluding the one or more fastening mechanisms 32, the deployment rods14, 16, 18 can be affixed to the implantable hernia prosthesis 12 byglue or other adhesive(s), staple(s), tack(s), welding, sintering, orthe like, so long as the fastening mechanism enables easy removal of thedeployment rods 14,16,18 without damaging the prosthesis. As yet afurther addition or alternative, the deployment rods 14, 16, 18 includebarbs that protrude through the implantable hernia prosthesis 12 (e.g.,through the mesh) and thereby fixedly maintain the deployment rods 14,16, 18 to the implantable hernia prosthesis 12, as would be readilyunderstood by those of skill in the art.

In illustrative embodiments, the fastening mechanisms 32 affixing thefirst deployment rod 14, the fastening mechanisms 32 affixing the seconddeployment rod 16, and the fastening mechanisms 32 affixing the thirddeployment rod 18 are all separately removable from the implantablehernia prosthesis 12. Accordingly, the fastening mechanisms 32 securingthe first deployment rod 14 to the implantable hernia prosthesis 12 areenabled to be removed without also removing the fastening mechanisms 32securing the second deployment rod 16 or the fastening mechanisms 32securing the third deployment rod 18. Likewise, the fastening mechanismssecuring the second deployment rod 16 to the implantable herniaprosthesis 12 are enabled to be removed without also removing thefastening mechanisms 32 securing the first deployment rod 14 or thefastening mechanisms 32 securing the third deployment rod 18. Similarly,the fastening mechanisms securing the third deployment rod 18 to theimplantable hernia prosthesis 12 are enabled to be removed without alsoremoving the fastening mechanisms 32 securing the first deployment rod14 or the fastening mechanisms 32 securing the second deployment rod 16.In this way, the deployment rods 14, 16, 18 can be provided asseparately removable from one another.

The deployment rods 14, 16, 18 can be of identical sizes and/or shapesor can have differing sizes and/or shapes. In general, each of thedeployment rods 14, 16, 18 has a central longitudinal axis 15, 17, 19.In the example embodiment of FIGS. 1 and 2, the deployment rods 14, 16,18 are more rigid than the implantable hernia prosthesis 12 (e.g., andthus can be substantially rigid relative to the flexible mesh sheetstructure forming the implantable hernia prosthesis 12). As such, thedeployment rods 14, 16, 18 can be configured to maintain the shape ofthe implantable hernia prosthesis 12 along the central longitudinal axes15, 17, 19 of the deployment rods 14, 16, 18. The deployment rods 14,16, 18 can be constructed of any suitable material enabling thedeployment rods 14, 16, 18 to have a rigidity that is sufficiently highto support the weight of the implantable hernia prosthesis 12 duringinsertion, deployment, and placement of the implantable herniaprosthesis 12. For example, the deployment rods 14, 16, 18 each can be awire rod formed of a medical grade metal. The particular size and shapeof the deployment rods 14, 16, 18 similarly can be selected (incombination with the materials) to provide the desired rigidity.

Due to their shape and rigidity, the deployment rods 14, 16, 18 providethe implantable hernia prosthesis 12 with structural reinforcement andincreased rigidity along only a single dimension of the implantablehernia prosthesis 12. In particular, the deployment rods 14, 16, 18reinforce and rigidify along the axis of the width 22 of the implantablehernia prosthesis 12 in the rolled configuration, thereby causing theimplantable hernia prosthesis 12 to exhibit greater resistance tobending along the axis of its width 22 when included in the system 10 inthe rolled configuration than it would when used as a stand-alonedevice—without disrupting the natural or inherent flexibility along theaxis of the length 20 of the implantable hernia prosthesis 12 whenconsidered as a stand-alone device. As such, the system 10 exhibitsgreater resistance to bends along the axis of the width 22 of theimplantable hernia prosthesis 12 than it does to bends along the axis ofthe length 20 of the implantable hernia prosthesis 12. Stated yetanother way, in accordance with the example embodiments describedherein, the deployment rods 14, 16, 18 effectively provide structuralreinforcement in such a way as to rigidify the implantable herniaprosthesis 12 only in the transverse direction, and not in thelongitudinal direction, as they have been illustrated in thecorresponding figures. Accordingly, when included in the system 10 inthe rolled configuration, the implantable hernia prosthesis 12 as awhole is capable of bending in a first direction (e.g., along its length20, in the example embodiment of FIGS. 1 and 2) while simultaneouslybeing hindered from bending in a second direction (e.g., along its width22, in the example embodiment of FIGS. 1 and 2) that is perpendicular tothe first direction. When rolled, the increased rigidity provided by thedeployment rods 14, 16, 18 assists with insertion of the implantablehernia prosthesis 12 through the trocar cannula or incision.Furthermore, in some embodiments, the deployment rods 14, 16, 18 canhave a relatively small diameter that does not significantly add to thethickness of the system 10. In this way, the total diameter of thesystem 10 when rolled can remain relatively small, as would be desiredin some medical applications where smaller trocar cannulas and/orincisions are utilized.

In operation (as shown in FIG. 9), the system 10 can be used inlaparoscopic hernia repair, as would be appreciated by one of skill inthe art upon reading the present specification. In particular, giventhat the natural flexibility of the length 20 of the implantable herniaprosthesis 12 is maintained even when included in the system 10, thesystem 10 can be rolled up (step 100) in a direction substantiallyorthogonal to the central longitudinal axes 15, 17, 19 (e.g., along thelength 20 of the implantable hernia prosthesis 12 in the exampleembodiment of FIGS. 1 and 2) without bending (i.e., with at most veryminimal or inconsequential bending) of the deployment rods 14, 16, 18.The step of rolling necessitates the previous placement of thedeployment rods 14, 16, 18 in the prosthesis, which could occur at anytime prior to rolling (e.g., at the point of manufacture, by the userjust prior to rolling, or at any point in-between), such that it may ormay not be a step prior to the step of rolling. As utilized herein, thephrase “without bending” refers to an overall requirement that thedeployment rods of the present invention be essentially or substantiallyrigid, such that the provide structure to the system 10 that enablesmanipulation and placement of the prosthesis. As such, a rod thatexperiences minimal, inconsequential (to the desired function), bendingwould be considered to be a rod that performs “without bending” inaccordance with the present invention, as would be appreciated by thoseskilled in the art. Once rolled in this way, the system 10 can beinserted into a patient, e.g., through one or more trocars (step 102).For example, FIG. 3 depicts the system 10 in such a rolled configuration(with the deployment rods 14, 16, 18 each unbent by the roll) prior tobeing implanted in a patient, in accordance with an example embodimentof the present invention. The rolled configuration of FIG. 3 can beproduced by gripping the system 10 at the second end 26 of the length 20of the implantable hernia prosthesis 12 and rolling the implantablehernia prosthesis 12 toward the first end 24 of the length 20 of theimplantable hernia prosthesis 12 until all or substantially all of thelength 20 of the implantable hernia prosthesis 12 is formed into a roll.

The system 10 is inserted into the body of a patient and advancedthrough one or more trocars to the site of the hernia defect (step 104),during which time a user can grip and manipulate the deployment rods 14,16, 18 using graspers. For example, by gripping the deployment rods 14,16, 18, a user can deploy (e.g., unroll) the system 10 and position thesystem 10 against the abdominal wall for fixation, as would beappreciated by one of skill in the art. In one illustrative embodiment,the system 10 is entirely unrolled by the user into the substantiallyflat configuration depicted in FIG. 1 and subsequently positionedagainst the defect site (step 106). Once adequately positioned, thesystem 10 can be affixed (step 108), e.g., using sutures and/or tacks,if desired (this step is optional depending on whether it is desirableor not to affix the prosthesis to the tissue). The deployment rods 14,16, 18 then can be detached/removed from the implantable herniaprosthesis 12 (step 110) and removed from the patient (step 112), e.g.,leaving behind only the affixed implantable hernia prosthesis 12.

In an alternative illustrative embodiment of the present invention, thesystem 10 is deployed and affixed in a piecewise and step-by-stepmanner, e.g., by repeating a process of unrolling and affixing discreteportions of the implantable hernia prosthesis 12. In particular, and asdepicted in FIG. 4, a portion of the system 10 can be unrolled, afterwhich (a) the fastening mechanisms 32 coupling the first deployment rod14 to the implantable hernia prosthesis 12 can optionally be removed and(b) the unrolled portion can be affixed to the surrounding tissue ormuscle wall at the defect site. The unrolled portion can be affixedusing one or more surgical sutures or tacks 34, as described previouslyherein. Next, subsequent to removing the fastening mechanisms 32securing the first deployment rod 14, the first deployment rod 14 can beremoved from the implantable hernia prosthesis 12. This process ofaffixing only a portion of the implantable hernia prosthesis 12 at atime can be repeated for remaining rolled portions of the implantablehernia prosthesis 12 (e.g., for those portions proximate the second andthird deployment rods 16, 18). In particular, after removing the firstdeployment rod 14, a medial portion of the implantable hernia prosthesis12 can be unrolled and affixed, and the second deployment rod 16 can beremoved from the implantable hernia prosthesis 12. Subsequent toremoving the second deployment rod 16, the remaining portion of theimplantable hernia prosthesis 12 disposed at the second end 26 of thelength 20 can be unrolled and affixed, and the third deployment rod 18can be removed from the implantable hernia prosthesis 12. In this way,the implantable hernia prosthesis 12 can be inserted into a patient,placed appropriately at the target site using the deployment rods 14,16, 18, and unrolled and affixed in a piecewise fashion using thedeployment rods 14, 16, 18.

Although three deployment rods 14, 16, 18 are illustrated in the exampleembodiment of FIGS. 1 through 4, it is alternatively contemplated thattwo, four, five, or more such deployment rods can be included in thesystem 10. For example, FIG. 5 depicts an embodiment of the system 10 inwhich only the first and second deployment rods 14, 16 are included. Inthe example embodiment of FIG. 5, the system 10 includes a prosthesis 12that is formed of a single flexible, substantially arch or fan-shapedmesh sheet structure. As with the embodiment of FIGS. 1 and 2, thedeployment rods 14, 16 of FIG. 5 are disposed across a majority of adimension of the prosthesis 12. However, unlike the example embodimentof FIGS. 1 and 2, in the example embodiment of FIG. 5, each of thedeployment rods 14, 16 is disposed across a majority of a radius 39 ofthe prosthesis 12. Furthermore, as with the example embodiment of FIG.1, the system 10 according to the example embodiment of FIG. 5 isconfigured to be rolled in a direction substantially orthogonal to thecentral longitudinal axes 15, 17 of the deployment rods 14, 16 in such away that all or substantially all of the prosthesis 12 (e.g., and thusall of the mesh sheet structure) forms one or more rolls withoutsubstantially or consequentially bending the deployment rods 14, 16.However, in the example embodiment of FIG. 5, the prosthesis 12 isconfigured to be rolled along in an angular direction 40, which issubstantially orthogonal to the central longitudinal axes 15, 17 of thedeployment rods 14, 16. As alluded to earlier herein, the deploymentrods 14, 16, while not substantially parallel prior to the rollingoperation, nonetheless result in a substantially parallel relativeorientation to each other when in the rolled configuration. This has todo with curved shape of the prosthesis 12, as would be appreciated bythose of skill in the art.

Although the implantable hernia prosthesis 12 of the example embodimentsof FIGS. 1 through 5 include only a single mesh sheet structure formingonly a single layer, the implantable hernia prosthesis 12 alternativelycan include two or more mesh sheet structures forming multiple layers.For example, FIG. 6 depicts the system 10 in which the implantablehernia prosthesis 12 includes a first flexible mesh sheet structure 36and a second flexible mesh sheet structure 38 coupled to the firstflexible mesh sheet structure 36. As depicted, the first and second meshsheet structures 36, 38 are coupled together near their outerperipheries. The second mesh sheet structure 38 is smaller in area thanand substantially similar in shape to the first mesh sheet structure 36.However, in some alternative embodiments, the first and second meshsheet structures 36, 38 are not similar in shape and/or size. The secondmesh sheet structure 38 forms a layer on the first mesh sheet structure36, and a pocket is formed between the first and second mesh sheetstructures 36, 38. The first and second deployment rods 14, 16 aredisposed within the pocket in such a way as to be removably coupled withthe implantable hernia prosthesis 12. Accordingly, the pocket formed bythe first and second mesh sheet structures 36, 38 is open at least atthe positions where the first and second deployment rods 14, 16 enterthe pocket. In the example embodiment of FIG. 6, the first and seconddeployment rods 14, 16 are disposed near the ends 24, 26 of the length20 of the implantable hernia prosthesis 12, as illustrated.

In some embodiments, the implantable hernia prosthesis 12 includes thetwo or more mesh sheet structures forming stacked layers and thedeployment rods 14, 16 are removably affixed to the implantable herniaprosthesis 12 by the one or more fastening mechanisms 32. For example,FIG. 7 depicts an embodiment according to the present invention, inwhich the deployment rods 14, 16 are affixed to the second mesh sheetstructure 38. FIG. 8 depicts an embodiment according to the presentinvention, in which the deployment rods 14, 16 are affixed to the firstmesh sheet structure 36. In some embodiments, the deployment rods 14, 16are affixed to both the first mesh sheet structure 36 and the secondmesh sheet structure 38 in such a way that the deployment rods 14, 16and the fastening mechanisms 32 appear substantially as shown in FIG. 7or FIG. 8 with the fastening mechanisms 32 instead passing through boththe first and second mesh sheet structures 36, 38. In this way, inembodiments in which the implantable hernia prosthesis 12 includes twomesh sheet structures, the deployment rods 14, 16 generally can becoupled to the first mesh sheet structure 36, the second mesh sheetstructure 38, or both.

Notably, the system 10 according to embodiments of the present inventionprovides a user with greater facility and ease of handling duringoperation. By providing two or more separate deployment rods 14, 16, 18removably affixed to the implantable hernia prosthesis 12 in asubstantially parallel arrangement, the system 10 permits users to rollthe implantable hernia prosthesis 12 and separately control andmanipulate various portions of the implantable hernia prosthesis 12.This has the beneficial effect of providing greater handlingcapabilities than known deployment devices presently utilized in the artwith hernia patches. Furthermore, providing that the deployment rods 14,16, 18 are separately removable allows a user to more easily work withdiscrete portions at a time, thereby reducing likelihood of tearing orrupturing unrolled portions, which remain protected in the rolledconfiguration (e.g., as illustrated in FIG. 4).

In addition, in accordance with embodiments of the present invention,the deployment rods 14, 16, 18 are configured to be manipulatedindependently of one another. Accordingly, the first deployment rod 14(disposed at the first end 24 of the length 20 of the implantable herniaprosthesis 12) is provided with a range of motion, the passage withinwhich does not inherently or necessarily effect motion of the secondand/or third deployment rods 16, 18. Similarly, the third deployment rod18 (disposed at the second end 26 of the length 20 of the implantablehernia prosthesis 12) is provided with a range of motion, whereinpassage of the third deployment rod 18 within the range of motion doesnot inherently or necessarily effect motion of the first and/or seconddeployment rods 14, 16. This capability for some independent motion andcontrol over the different deployment rods 14, 16, 18 provides a userwith greater handling capabilities by enabling more focused control oversmaller and more discrete portions of the implantable hernia prosthesis12. Upon reading the present specification, one of skill in the art willappreciate yet further benefits not described herein.

Numerous modifications and alternative embodiments of the presentinvention will be apparent to those skilled in the art in view of theforegoing description. Accordingly, this description is to be construedas illustrative only and is for the purpose of teaching those skilled inthe art the best mode for carrying out the present invention. Details ofthe structure may vary substantially without departing from the spiritof the present invention, and exclusive use of all modifications thatcome within the scope of the appended claims is reserved. Within thisspecification embodiments have been described in a way which enables aclear and concise specification to be written, but it is intended andwill be appreciated that embodiments may be variously combined orseparated without parting from the invention. It is intended that thepresent invention be limited only to the extent required by the appendedclaims and the applicable rules of law.

It is also to be understood that the following claims are to cover allgeneric and specific features of the invention described herein, and allstatements of the scope of the invention which, as a matter of language,might be said to fall therebetween.

What is claimed is:
 1. A system, comprising: a prosthesis comprising afirst flexible mesh sheet structure; and two or more elongate rods eachbeing removably coupled with the prosthesis and each being more rigidthan the mesh sheet structure, in such a way that the combination of thetwo or more elongate rods with the mesh sheet structure rigidifies themesh sheet structure along a length of each of the two or more elongaterods; wherein the system is configured to be rolled in a directionsubstantially orthogonal to a central longitudinal axes of the two ormore elongate rods in such a way that all or substantially all of themesh sheet structure forms one or more rolls without bending the two ormore elongate rods.
 2. The system of claim 1, wherein the two or moreelongate rods are separate and distinct from each other and two of thetwo or more elongate rods are independently moveable relative to eachother.
 3. The system of claim 1, further comprising one or morefastening mechanisms coupling the two or more elongate rods to the firstmesh sheet structure of the prosthesis.
 4. The system of claim 3,wherein each one of the two or more elongate rods is slidable out of theone or more fastening mechanisms in a direction generally along thecentral longitudinal axis of that one of the two or more elongate rods.5. The system of claim 3, wherein the one or more fastening mechanismsare configured to be cut to release the two or more elongate rods andare configured to be removed from the mesh sheet structure.
 6. Thesystem of claim 1, wherein the prosthesis further comprises a secondflexible mesh sheet structure coupled to and forming a layer on thefirst mesh sheet structure.
 7. The system of claim 6, wherein the two ormore elongate rods are disposed between the first and second mesh sheetlayers which removably couple the two or more elongate rods to the sheetin such a way that the two or more elongate rods are slidable out frombetween the first and second mesh sheet structures.
 8. The system ofclaim 1, wherein the prosthesis further comprises a second flexible meshsheet structure coupled to and forming a layer on the first mesh sheetstructure, and wherein each of the two or more elongate rods are affixedto the first flexible mesh sheet structure, the second flexible meshsheet structure, or both.
 9. The system of claim 1, wherein at least oneof the two or more elongate rods coupled to the prosthesis extendsbeyond and exterior to a perimeter edge of the prosthesis.
 10. Thesystem of claim 1, wherein at least one of the two or more elongate rodscoupled to the prosthesis is graspable and maneuverable by alaparoscopic grasper or other separate tool.
 11. The system of claim 1,wherein each of the two or more elongate rods extends across a majorityof a dimension of the prosthesis.
 12. The system of claim 1, wherein afirst of the two or more elongate rods is disposed at a first end of theprosthesis and a second of the two or more elongate rods is disposed ata second end of the prosthesis, the second end of the prosthesis beingopposite the first end.
 13. The system of claim 12, wherein the two ormore elongate rods further comprise a third rod disposed between thefirst and second rods at a central portion of the prosthesis.
 14. Thesystem of claim 1, wherein the two or more elongate rods have a rigiditysuitable for using the two or more elongate rods to manipulate andposition the prosthesis at a target site.
 15. The system of claim 1,wherein each of the two or more elongate rods comprises a wire rod or aplastic rod.
 16. A method for deploying a mesh prosthesis using a systemcomprising a prosthesis comprising a first flexible mesh sheetstructure, and two or more elongate rods each being removably coupledwith the prosthesis and each being more rigid than the mesh sheetstructure in such a way that the combination of the two or more elongaterods with the mesh sheet structure rigidifies the mesh sheet structurealong a length of each of the two or more elongate rods, the methodcomprising: providing a rolled prosthesis in which, using the two ormore elongate rods, the prosthesis is rolled in a directionsubstantially orthogonal to a central longitudinal axes of the two ormore elongate rods in such a way that all or substantially all of themesh sheet structure forms one or more rolls without bending the two ormore elongate rods; inserting the prosthesis into a bodily cavity;unrolling the prosthesis, using the two or more elongate rods; andremoving the two or more elongate rods from the prosthesis.
 17. Themethod of claim 16, wherein the two or more elongate rods are separateand distinct from each other and two of the two or more elongate rodsare independently moveable relative to each other.
 18. The method ofclaim 16, further comprising one or more fastening mechanisms couplingthe two or more elongate rods to the first mesh sheet structure of theprosthesis.
 19. The method of claim 16, wherein removing the two or moreelongate rods comprises sliding the two or more elongate rods out of theone or more fastening mechanisms in a direction generally along thecentral longitudinal axis of each respective rod of the two or moreelongate rods.
 20. The method of claim 16, wherein the prosthesisfurther comprises a second flexible mesh sheet structure coupled to andforming a layer on the first mesh sheet structure.
 21. The method ofclaim 20, wherein the two or more elongate rods are disposed between thefirst and second mesh sheet layers which removably couple the two ormore elongate rods to the sheet in such a way that the step of removingthe two or more elongate rods comprises sliding the two or more elongaterods out from between the first and second mesh sheet structures. 22.The method of claim 16, wherein at least one of the two or more elongaterods coupled to the prosthesis extends beyond and exterior to aperimeter edge of the prosthesis.
 23. The method of claim 16, wherein atleast one of the two or more elongate rods coupled to the prosthesis isgraspable and maneuverable by a laparoscopic grasper or other separatetool.
 24. The method of claim 16, wherein the two or more elongate rodshave a rigidity suitable for using the two or more elongate rods tomanipulate and position the prosthesis at a target site, furthercomprising manipulating and positioning the prosthesis at the targetsite using the two or more elongate rods.
 25. The method of claim 16,wherein the step of providing the rolled prosthesis comprises theprosthesis being rolled at a point of manufacture.
 26. The method ofclaim 16, wherein the step of providing the rolled prosthesis comprisesa user using the two or more elongate rods to roll the prosthesis in adirection substantially orthogonal to the central longitudinal axes ofthe two or more elongate rods in such a way that all or substantiallyall of the mesh sheet structure forms one or more rolls without bendingthe two or more elongate rods and prior to the user inserting theprosthesis into a bodily cavity.
 27. A system, comprising: a prosthesiscomprising a first flexible mesh sheet structure; and two or moreelongate rods each being removably coupled with the prosthesis and eachbeing more rigid than the mesh sheet structure, in such a way that thecombination of the two or more elongate rods with the mesh sheetstructure rigidifies the mesh sheet structure along a length of each ofthe two or more elongate rods; wherein the system is configured to berolled in a direction substantially orthogonal to a central longitudinalaxes of the two or more elongate rods in such a way that all orsubstantially all of the mesh sheet structure forms one or more rolls;and wherein the two or more elongate rods are separate and distinct fromeach other and two of the two or more elongate rods are independentlymoveable relative to each other.
 28. A system, comprising: a prosthesiscomprising a first flexible mesh sheet structure; and two or moreelongate rods each being removably coupled with the prosthesis and eachbeing more rigid than the mesh sheet structure, in such a way that thecombination of the two or more elongate rods with the mesh sheetstructure rigidifies the mesh sheet structure along a length of each ofthe two or more elongate rods; wherein the system is configured to berolled in a direction substantially orthogonal to a central longitudinalaxes of the two or more elongate rods in such a way that all orsubstantially all of the mesh sheet structure forms one or more rolls;wherein the two or more elongate rods are separate and distinct fromeach other and two of the two or more elongate rods are independentlymoveable relative to each other; and wherein the two or more elongaterods have sufficient rigidity to enable use of the two or more elongaterods to manipulate and position the prosthesis at a target site.